Tafoxiparin, a novel drug candidate for cervical ripening and labor augmentation: results from 2 randomized, placebo-controlled studies.

BACKGROUND: Slow progression of labor is a common obstetrical problem with multiple associated complications. Tafoxiparin is a depolymerized form of heparin with a molecular structure that eliminates the anticoagulant effects of heparin. We report on 2 phase II clinical studies of tafoxiparin in primiparas. Study 1 was an exploratory, first-in-pregnant-women study and study 2 was a dose-finding study. OBJECTIVE: Study 1 was performed to explore the effects on labor time of subcutaneous administration of tafoxiparin before onset of labor. Study 2 was performed to test the hypothesis that intravenous treatment with tafoxiparin reduces the risk for prolonged labor after spontaneous labor onset in situations requiring oxytocin stimulation because of dystocia. STUDY DESIGN: Both studies were randomized, double-blind, and placebo-controlled. Participants were healthy, nulliparous females aged 18 to 45 years with a normal singleton pregnancy and gestational age confirmed by ultrasound. The primary endpoints were time from onset of established labor (cervical dilation of 4 cm) until delivery (study 1) and time from start of study treatment infusion until delivery (study 2). In study 1, patients at 38 to 40 weeks of gestation received 60 mg tafoxiparin or placebo daily as 0.4 mL subcutaneous injections until labor onset (maximum 28 days). In study 2, patients experiencing slow progression of labor, a prolonged latent phase, or labor arrest received a placebo or 1 of 3 short-term tafoxiparin regimens (initial bolus 7, 21, or 35 mg followed by continuous infusion at 5, 15, or 25 mg/hour until delivery; maximum duration, 36 hours) in conjunction with oxytocin. RESULTS: The number of participants randomized in study 1 was 263, and 361 were randomized in study 2. There were no statistically significant differences in the primary endpoints between those receiving tafoxiparin and those receiving the placebo in both studies. However, in study 1, the risk for having a labor time exceeding 12 hours was significantly reduced by tafoxiparin (tafoxiparin 6/114 [5%] vs placebo 18/101 [18%]; P=.0045). Post hoc analyses showed that women who underwent labor induction had a median (range) labor time of 4.44 (1.2-8.5) hours with tafoxiparin and 7.03 (1.5-14.3) hours with the placebo (P=.0041) and that co-administration of tafoxiparin potentiates the effect of oxytocin and facilitates a shorter labor time among women with a labor time exceeding 6 to 8 hours (P=.016). Among women induced into labor, tafoxiparin had a positive effect on cervical ripening in 11 of 13 cases (85%) compared with 3 of 13 participants (23%) who received the placebo (P=.004). For women requiring oxytocin because of slow progression of labor, the corresponding results were 34 of 51 participants (66%) vs 16 of 40 participants (40%) (P=.004). In study 2, tafoxiparin had no positive effects on the secondary endpoints when compared with the placebo. Except for injection-site reactions in study 1, adverse events were no more common for tafoxiparin than for the placebo among either mothers or infants. There were few serious or treatment-related adverse events. CONCLUSION: Subcutaneous treatment with tafoxiparin before labor onset (study 1) may be effective in reducing the labor time among women undergoing labor induction and among those requiring oxytocin for slow progression of labor. Moreover, tafoxiparin may have a positive effect on cervical ripening. Short-term, intravenous treatment with tafoxiparin as an adjunct to oxytocin in patients with labor arrest (study 2) did not affect labor time or other endpoints. Both studies suggest that tafoxiparin has a favorable safety profile in mothers and their infants.

Complications 8 weeks after an obstetric second-degree perineal laceration in relation to body mass index.

INTRODUCTION AND HYPOTHESIS: How body mass index (BMI) affects pelvic floor function after a second-degree perineal laceration is unknown. The hypothesis of this study is that pelvic floor dysfunction and complications after an obstetric second-degree perineal laceration are more common in women with a higher BMI 8 weeks postpartum. METHODS: This register-based cohort study includes 10,876 primiparous women with an obstetric second-degree perineal laceration between 2014 and 2021. Data were retrieved from the Swedish Perineal Laceration Registry. Outcomes in relation to maternal BMI were urinary incontinence (UI), anal incontinence (AI) and common complications attributable to the laceration. Uni- and multivariate logistic regressions were used for comparison between normal weight (BMI < 24.9, reference), overweight (25.0-29.9) and obese (≥ 30) women. RESULTS: Multivariate analyses showed an increased risk for UI in both overweight and obese women compared to normal-weight women 8 weeks after a second-degree perineal laceration with an adjusted odds ratio (aOR) of 1.21 (CI 1.02-1.44) and 1.27 (CI 1.13-1.58) respectively. Overweight and obese women had a decreased risk for AI (aOR 0.81, CI 0.68-0.96; aOR 0.72, CI 0.57-0.90 respectively) compared with normal-weight women. No significant differences were found in the univariate analyses over BMI strata concerning complications after perineal laceration. CONCLUSIONS: Primiparous overweight and obese women report less AI and more UI than normal-weight women 8 weeks after a second-degree perineal laceration. No differences were found regarding complications. These findings are new and merit further study to find potential preventive factors and interventions after a second-degree perineal laceration.

The association between maternal vitamin D deficiency and postpartum hemorrhage and uterine atony.

INTRODUCTION: Postpartum hemorrhage is the leading cause of maternal morbidity and mortality worldwide. There are several known risk factors for postpartum hemorrhage related to pregnancy and delivery, but less evidence of predisposing factors. Recent research has shown that vitamin D deficiency may increase the risk of cesarean section due to dystocia, based on its effect on striated muscle as well as possible effect on the myometrium. Whether vitamin D deficiency increases the risk for postpartum hemorrhage and especially atonic hemorrhage is unknown. MATERIAL AND METHODS: This was a retrospective translational study. The study population included 1367 women in Sweden and the main exposure was the serum concentration of 25-hydroxylated vitamin D at time of delivery. The LIASON® 25 OH vitamin D total assay method was used for analyzing 25-hydroxylated vitamin D. Vitamin D insufficiency was defined as serum concentration <50 nmol/L and vitamin D deficiency as serum concentrations <25 nmol/L. Primary outcomes were postpartum hemorrhage and severe postpartum hemorrhage defined as bleeding ≥500 mL and ≥ 1000 mL, respectively 2 h after delivery. Secondary outcome was atonic postpartum hemorrhage. Crude and adjusted odds ratios were calculated with 95% confidence intervals using univariable and multivariable logistic regression. Three different adjustment methods were used, adjusting for maternal, obstetrical and neonatal confounders. RESULTS: Postpartum hemorrhage and severe postpartum hemorrhage afflicted 31.3% and 6.4% of the women, respectively. Rate of atonic postpartum hemorrhage was 21% in the whole population. Rate of vitamin D insufficiency and deficiency was 57%. Vitamin D insufficiency or deficiency was neither found to be associated with postpartum hemorrhage, nor with atonic postpartum hemorrhage. CONCLUSIONS: In this study, the vitamin D status of women at the time of delivery was not a predictor of postpartum hemorrhage overall or atonic postpartum hemorrhage.

Prominent epigenetic and transcriptomic changes in CD4+ and CD8+ T cells during and after pregnancy in women with multiple sclerosis and controls.

BACKGROUND: Multiple sclerosis (MS) is a neuroinflammatory disease in which pregnancy leads to a temporary amelioration in disease activity as indicated by the profound decrease in relapses rate during the 3rd trimester of pregnancy. CD4+ and CD8+ T cells are implicated in MS pathogenesis as being key regulators of inflammation and brain lesion formation. Although Tcells are prime candidates for the pregnancy-associated improvement of MS, the precise mechanisms are yet unclear, and in particular, a deep characterization of the epigenetic and transcriptomic events that occur in peripheral T cells during pregnancy in MS is lacking. METHODS: Women with MS and healthy controls were longitudinally sampled before, during (1st, 2nd and 3rd trimesters) and after pregnancy. DNA methylation array and RNA sequencing were performed on paired CD4+ and CD8+ T cells samples. Differential analysis and network-based approaches were used to analyze the global dynamics of epigenetic and transcriptomic changes. RESULTS: Both DNA methylation and RNA sequencing revealed a prominent regulation, mostly peaking in the 3rd trimester and reversing post-partum, thus mirroring the clinical course with improvement followed by a worsening in disease activity. This rebound pattern was found to represent a general adaptation of the maternal immune system, with only minor differences between MS and controls. By using a network-based approach, we highlighted several genes at the core of this pregnancy-induced regulation, which were found to be enriched for genes and pathways previously reported to be involved in MS. Moreover, these pathways were enriched for in vitro stimulated genes and pregnancy hormones targets. CONCLUSION: This study represents, to our knowledge, the first in-depth investigation of the methylation and expression changes in peripheral CD4+ and CD8+ T cells during pregnancy in MS. Our findings indicate that pregnancy induces profound changes in peripheral T cells, in both MS and healthy controls, which are associated with the modulation of inflammation and MS activity.

Gestational diabetes mellitus and time in active labor: A population-based cohort study.

INTRODUCTION: Women with gestational diabetes mellitus (GDM) have higher rates of adverse perinatal outcomes compared with women without GDM, including an increased risk for having labor induced and for cesarean section. The findings from previous studies analyzing duration of labor in women with GDM are contradictory. The aim of the study was to evaluate the impact of GDM on time in spontaneous and induced active labor. MATERIAL AND METHODS: This was a population-based cohort study including 247 524 primiparous women who gave birth to a singleton fetus with cephalic presentation, ≥34+0 (completed gestational weeks + additional days) between January 2014 and May 2020 in Sweden. Data was obtained from the Swedish Pregnancy Register. Time in active labor was compared between women with GDM and without GDM with a spontaneous labor onset or induction of labor using Kaplan Meier survival analysis and Cox regression analysis. RESULTS: Women with GDM had significantly longer time in active labor, both with a spontaneous onset and induction of labor compared to women without GDM. Women with GDM had a decreased chance of vaginal delivery at a certain time-point compared to women without GDM, with adjusted hazard ratio of 0.92 (0.88-0.96) and 0.83 (0.76-0.90) for those with spontaneous onset and induction of labor, respectively. Women with GDM had increased risk for time in active labor ≥12 h both in spontaneous labor onset (adjusted odds ratio 1.14 [1.04-1.25]) and in induction of labor (adjusted odds ratio 1.55 [1.28-1.87]). CONCLUSIONS: Women with GDM seem to spend a longer time in active labor, both in spontaneous and induced active labor compared to women without GDM. To be able to individualize care intrapartum, there is a need for more studies demonstrating the impact of hyperglycemia during pregnancy on outcomes during childbirth.

Key outcomes in childbirth: Development of a perinatal core outcome set for management of labor and delivery at or near term.

INTRODUCTION: Consistency and relevance of perinatal outcome measures are necessary basics for obstetric research, audit, and clinical counseling. Still, there is an unwarranted variation in reported perinatal outcomes, which impairs research synthesis, validity, and implementation, as well as clinical benchmarking and longitudinal comparisons. The aim of this study was to develop a short-term perinatal (fetal and neonatal) Core Outcome Set to be used in research and quality assurance of management of labor and delivery at or near term. MATERIAL AND METHODS: The methods were guided by the Core Outcome Measures in Effectiveness Trials Initiative Handbook. The project was prospectively registered on July 2, 2020 in the Core Outcome Measures in Effectiveness Trials (COMET) data base (reference number 1593). A list of potential outcomes was created based on a systematic review of studies evaluating interventions for peripartum management at or near term (≥34 weeks of gestation), including decisions regarding timing and type of onset of labor, intrapartum care, and mode of delivery. The list was entered into a two-round Delphi survey with predefined consensus criteria. Participants (n = 67) included clinicians, researchers, lay persons with experience of childbirth (patient representatives), and other stakeholders. A consensus meeting was held to reach a final agreement. RESULTS: Response rates were 82.1% (55/67) and 92.7% (51/55) for the first and second Delphi rounds, respectively. In total, 17 outcomes were included in the final core outcome set, reflecting mortality, health or morbidity, including asphyxia, central nervous system status, infection, neonatal resuscitation and admission, breastfeeding and mother-infant interaction, operative delivery due to fetal distress, as well as birthweight and gestational age. Two of these outcomes were suggested by patient representatives. CONCLUSIONS: The Swedish Perinatal Core Outcome Set (SPeCOS) study involved a broad circle of relevant stakeholders and reached consensus on a minimal set of perinatal outcomes that should be collected and reported in a standardized way in all future studies on management of labor and delivery at or near term, regardless of the specific population or condition studied. This could improve obstetric research, evidence synthesis, uptake, implementation, and adherence, as well as clinical practice, audit, and comparisons in childbirth care.

Student-led clinic cervical cancer screening-medical students' views on progression of learning, quality of Pap smears and women´s experiences of the visit - a mixed methods study.

BACKGROUND: Student-led clinics (SLC) have been described, but not in gynecology. Gynecology is a subject typically covered in the last terms of medical training, however it includes few opportunities for students to tackle all phases of a consultation and a shortage of opportunities to perform gynecological examinations. Therefore, we started a student-led clinic for cervical cancer screening (SLC-CCS) in Linköping, Sweden and aimed to evaluate students' views on the progression of learning, the quality of the Papanicolaou (Pap) smear, and women´s experiences of the visit, using mixed methodology. METHODS: The implementation of the SLC-CCS is described in detail. Students (n = 61) taking part in the SLC-CCS between January and May 2021 were invited to participate in a follow-up discussion (n = 24) focused around four themes: attitudes and expectations prior to participation, experiences of the patient encounter, organization of the placement, and reflections on and suggestions for further development of the placements. The group meetings were conducted in Swedish, recorded, transcribed verbatim and subjected to a qualitative, descriptive thematic analysis. Thematic analysis is considered an appropriate method of analysis for seeking to understand experiences, thoughts, or behaviors across a data set. The proportion of Pap smears lacking cells from the squamous epithelium during the study period was compared with data from the same clinic before the SLC-CCS started. A validated questionnaire on women's experience of the Pap smear visit was provided. Answers were compared between women who had the Pap smear taken by a student or a healthcare provider. RESULTS: Three different themes were generated: growing confidence in the clinical situation, embodied awareness of variation in anatomy, doubting accuracy of one's own performance. The percentage of Pap smears lacking cells from the squamous epithelium were equal (2%) during the study period compared to the period before the SLC-CCS started (p = 0.28). No difference was found in the satisfaction index between the women examined by a student, those examined by a healthcare provider, or women who did not know who the examiner was (p = 0.112). CONCLUSIONS: The students expressed a growing confidence in the clinical situation and there was high satisfaction from the women. The quality of the Pap smears taken by the students was equal to the quality of those taken by the health care staff. All these findings indicate that high patient safety was maintained during this activity support the recommendation to include SLC-CCS as part of the medical training.

Association Between History of Adverse Pregnancy Outcomes and Coronary Artery Disease Assessed by Coronary Computed Tomography Angiography.

Importance: Adverse pregnancy outcomes are recognized risk enhancers for cardiovascular disease, but the prevalence of subclinical coronary atherosclerosis after these conditions is unknown. Objective: To assess associations between history of adverse pregnancy outcomes and coronary artery disease assessed by coronary computed tomography angiography screening. Design, Setting, and Participants: Cross-sectional study of a population-based cohort of women in Sweden (n = 10 528) with 1 or more deliveries in 1973 or later, ascertained via the Swedish National Medical Birth Register, who subsequently participated in the Swedish Cardiopulmonary Bioimage Study at age 50 to 65 (median, 57.3) years in 2013-2018. Delivery data were prospectively collected. Exposures: Adverse pregnancy outcomes, including preeclampsia, gestational hypertension, preterm delivery, small-for-gestational-age infant, and gestational diabetes. The reference category included women with no history of these exposures. Main Outcomes and Measures: Coronary computed tomography angiography indexes, including any coronary atherosclerosis, significant stenosis, noncalcified plaque, segment involvement score of 4 or greater, and coronary artery calcium score greater than 100. Results: A median 29.6 (IQR, 25.0-34.9) years after first registered delivery, 18.9% of women had a history of adverse pregnancy outcomes, with specific pregnancy histories ranging from 1.4% (gestational diabetes) to 9.5% (preterm delivery). The prevalence of any coronary atherosclerosis in women with a history of any adverse pregnancy outcome was 32.1% (95% CI, 30.0%-34.2%), which was significantly higher (prevalence difference, 3.8% [95% CI, 1.6%-6.1%]; prevalence ratio, 1.14 [95% CI, 1.06-1.22]) compared with reference women. History of gestational hypertension and preeclampsia were both significantly associated with higher and similar prevalence of all outcome indexes. For preeclampsia, the highest prevalence difference was observed for any coronary atherosclerosis (prevalence difference, 8.0% [95% CI, 3.7%-12.3%]; prevalence ratio, 1.28 [95% CI, 1.14-1.45]), and the highest prevalence ratio was observed for significant stenosis (prevalence difference, 3.1% [95% CI, 1.1%-5.1%]; prevalence ratio, 2.46 [95% CI, 1.65-3.67]). In adjusted models, odds ratios for preeclampsia ranged from 1.31 (95% CI, 1.07-1.61) for any coronary atherosclerosis to 2.21 (95% CI, 1.42-3.44) for significant stenosis. Similar associations were observed for history of preeclampsia or gestational hypertension among women with low predicted cardiovascular risk. Conclusions and Relevance: Among Swedish women undergoing coronary computed tomography angiography screening, there was a statistically significant association between history of adverse pregnancy outcomes and image-identified coronary artery disease, including among women estimated to be at low cardiovascular disease risk. Further research is needed to understand the clinical importance of these associations.

Clinical-pathological features in placentas of pregnancies with SARS-CoV-2 infection and adverse outcome: case series with and without congenital transmission.

OBJECTIVE: To correlate clinical outcomes to pathology in SARS-CoV-2 infected placentas in stillborn and live-born infants presenting with fetal distress. DESIGN: Retrospective, observational. SETTING: Nationwide. POPULATION: Five stillborn and nine live-born infants from 13 pregnant women infected with SARS-CoV-2 seeking care at seven different maternity units in Sweden. METHODS: Clinical outcomes and placental pathology were studied in 14 cases (one twin pregnancy) of maternal SARS-CoV-2 infection with impaired fetal outcome. Outcomes were correlated to placental pathology in order to investigate the impact of virus-related pathology on the villous capillary endothelium, trophoblast and other cells. MAIN OUTCOME MEASURES: Maternal and fetal clinical outcomes and placental pathology in stillborn and live-born infants. RESULTS: Reduced fetal movements were reported (77%) and time from onset of maternal COVID-19 symptoms to signs of fetal distress among live-born infants was 6 (3-12) days and to diagnosis of stillbirth 11 (2-25) days. Two of the live-born infants died during the postnatal period. Signs of fetal distress led to emergency caesarean section in all live-born infants with umbilical cord blood gases and low Apgar scores confirming intrauterine hypoxia. Five stillborn and one live-born neonate had confirmed congenital transmission. Massive perivillous fibrinoid deposition, intervillositis and trophoblast necrosis were associated with SARS-CoV-2 placental infection and congenital transmission. CONCLUSIONS: SARS-CoV-2 can cause rapid placental dysfunction with subsequent acute fetal hypoxia leading to intrauterine fetal compromise. Associated placental pathology included massive perivillous fibrinoid deposition, intervillositis and trophoblast degeneration.

Body mass index and complications after obstetric anal sphincter injury, 8 weeks postpartum.

INTRODUCTION AND HYPOTHESIS: The impact of body mass index (BMI) on pelvic floor recovery after an obstetric anal sphincter injury (OASI) is unclear. The aim of this study was to evaluate the hypothesis that urinary incontinence (UI) and anal incontinence (AI) are more common in overweight and obese women than in normal-weight women 8 weeks postpartum in women with OASI. METHODS: A population-based cohort study including 6,595 primiparous women, with an OASI, delivered between 2014 and 2019. Exposure and questionnaire data were retrieved from the Swedish Perineal Laceration Registry. Uni- and multivariate analyses were used to compare normal-weight (BMI ≤24.9, reference), overweight (25.0-29.9), and obese (≥ 30) women with regard to UI and AI at 8 weeks post-partum. RESULTS: Multivariate analyses showed an increased risk for urinary incontinence (OR 1.54, 95% CI 1.27-1.87) among overweight women as well as among obese women (OR 1.72, 95% CI 1.32-2.24). In contrast to our hypothesis, both overweight women (OR 0.68, 95% CI 0.56-0.83) and obese women (OR 0.65, 95% CI 0.49-0.87) were at a decreased risk for any gas and/or faecal incontinence after adjustment to possible confounding factors. The absolute rate of AI was 40.1% among normal-weight women, 34.2% among overweight women, and 29.1% in the obese group. CONCLUSIONS: Urinary incontinence is more common, whereas AI is less common among overweight and obese women than in primiparous women with a BMI <24.9, 8 weeks after an OASI. The new finding, that overweight women report less AI than normal-weight women, merits further study.

Labor dystocia and oxytocin augmentation before or after six centimeters cervical dilatation, in nulliparous women with spontaneous labor, in relation to mode of birth.

BACKGROUND: The effects of diagnosing and treating labor dystocia with oxytocin infusion at different cervical dilatations have not been fully evaluated. Therefore, we aimed to examine whether cervical dilatation at diagnosis of dystocia and initiation of oxytocin infusion at different stages of cervical dilatation were associated with mode of birth, obstetric complications and women's birthing experience. METHODS: A retrospective cohort study, including 588 nulliparous term women with spontaneous onset of labor and dystocia requiring oxytocin augmentation. The study population was divided into three groups according to cervical dilatation at diagnosis of dystocia and initiation of oxytocin-infusion (≤ 5 cm, 6-10 cm, fully dilated) with mode of birth as the primary outcome. Secondary outcomes were obstetrical and neonatal complications and women´s experience of childbirth. Statistical comparison between groups using Chi-square and ANOVA was performed. The risk of operative birth (cesarean section and instrumental birth) was assessed using binary logistic regression with suitable adjustments (maternal age, body mass index and risk assessment on admission to the labor ward). RESULTS: The cesarean section rate differed between the groups (p < 0.001); 12% in the ≤ 5 cm group, 6% in the 6-10 cm group and 0% in the fully dilated group. There was no increased risk for operative birth in the ≤ 5 cm group compared to the 6-10 cm group, adjusted OR 1.28 95%CI (0.78-2.08). The fully dilated group had a decreased risk of operative birth (adjusted OR 0.48 95%CI (0.27-0.85). The rate of a negative birthing experience was high in all groups (28.5%, 19% and 18%) but was only increased among women in the ≤ 5 cm group compared with the 6-10 cm group, adjusted OR 1.76 95%CI (1.05-2.95). CONCLUSIONS: Although no difference in the risk of operative birth was found between the ≤ 5 cm and 6-10 cm cervical dilatation-groups, the cesarean section rate was highest in women with dystocia requiring oxytocin augmentation at ≤ 5 cm cervical dilatation. This might indicate that oxytocin augmentation before 6 cm cervical dilatation could be contra-productive in preventing cesarean sections. Further, the increased risk of negative birth experience in the ≤ 5 cm group should be kept in mind to improve labor care.

Long-term effects of the nine-item list intervention on obstetric and neonatal outcomes in Robson group 1 - A time series study.

INTRODUCTION: The nine-item list, with organizational and cultural changes, was implemented at the delivery unit in Linköping, Sweden between 2007 and 2010, aiming at improving the quality of care by offering more women a safe and attractive vaginal delivery. The target group for the intervention was nulliparous women at term with spontaneous onset of labor and cephalic presentation (Robson group 1). The aim of this study was to evaluate pregnancy outcomes before, during, early post and late post introduction of the nine-item list. MATERIAL AND METHODS: Robson group 1 births (n = 12 763) from 2004 to 2018 were divided into four time periods; before the nine-item list (2004-2006), during introduction of the nine-item list (2007-2010), early post introduction of the nine-item list (2011-2014) and late post introduction of the nine-item list (2015-2018). The nine-item list consists of monitoring of obstetric results, midwife coordinator, risk classification of women, three midwife-competence levels, teamwork-the midwife, obstetrician and nurse working as a team with the common goal of a normal delivery, obstetric morning round, fetal monitoring skills and obstetric skills training. Perinatal outcomes before, during, early post and late post introduction were compared using a Student's t test for numerical variables and a Pearson chi-squared test for categorical variables. RESULTS: Apgar score <7 at 5 minutes, Apgar score <4 at 5 minutes and umbilical cord arterial pH <7 did not differ significantly between the four time periods. Between before introduction and early post introduction, instrumental vaginal delivery decreased from 19.8% to 12.2% and cesarean section from 9.6% to 4.5%. The late post introduction period showed a maintained effect with 10.7% instrumental deliveries and 3.9% cesarean sections. Obstetric anal sphincter injury grade III decreased instantly during the introduction of the nine-item list from 7.8% to 5.1% and thereafter remained unchanged. CONCLUSIONS: Implementation of the nine-item list increased the proportion of spontaneous vaginal deliveries by reducing the number of instrumental deliveries and cesarean sections without affecting the neonatal outcomes in nulliparous women with spontaneous onset of labor. The nine-item list intervention seems to provide long-term sustainable results.

Success rate of external cephalic version in relation to the woman's body mass index and other factors-a population-based cohort study.

INTRODUCTION: The aim of this study was to evaluate the impact of women's body mass index (BMI) on the probability of a successful external cephalic version (ECV). MATERIAL AND METHODS: A retrospective population-based observational study including all women that underwent an ECV in the southeast region of Sweden from January 2014 to December 2019. Data were collected from electronic medical records, Obstetrix, Cerner. The women were divided into BMI categories according to the World Health Organization classification. Women with a BMI below 25 kg/m2 formed the reference group. Crude and adjusted odds ratios for unsuccessful ECV in each BMI group were calculated using binary logistic regression. Furthermore, the association between maternal characteristics and clinical and ultrasound variables at the time of the ECV and unsuccessful ECV was evaluated. RESULTS: A total of 2331 women were included. The overall success rate of ECV was 53.4%. Women with a BMI below 25 kg/m2 had a success rate of 51.3% whereas obese women had a success rate of 58.6%. The risk of an unsuccessful ECV among obese women (BMI ≥30 kg/m2 ) had an OR of 0.74 (95% CI 0.59-0.94) compared with women with a BMI below 25 kg/m2 . After adjusting for suitable confounding factors, the association was no longer significant. Higher maternal age, multiparity, higher gestational age, posterior placenta position, polyhydramnios and higher estimated weight of the fetus at the ECV significantly decreased the risk of an unsuccessful ECV. CONCLUSIONS: Maternal obesity does not seem to negatively influence the success rate of ECV. This is a finding that may encourage both caregivers and obese pregnant women to consider an ECV and so avoid a planned cesarean section for breech presentation in this group.

Evaluation of venous plasma glucose measured by point-of-care testing (Accu-Chek Inform II) and a hospital laboratory hexokinase method (Cobas c701) in oral glucose tolerance testing during pregnancy - a challenge in diagnostic accuracy.

To diagnose gestational diabetes mellitus (GDM), plasma glucose measurements during oral glucose tolerance test (OGTT) put high demands on the methods in terms of accuracy. The aim was to evaluate and compare diagnostic performance of a point-of-care test and a glucose hexokinase laboratory method. Using risk-based screening, 175 pregnant women were included. They underwent a 75 g OGTT in their 28th (median) week of gestation. Venous blood was collected in two different tubes. Plasma glucose was measured on Cobas c701 and in duplicates on AccuChek Inform II (both methods from Roche Diagnostics). Accuracy was assessed by participating in external control programs with reference method assigned values. The methods were compared for all samples (n = 512) by regression analysis; slope of 0.90 (95% CI: 0.89-0.92), intercept of 0.12 (95% CI: 0.011-0.22) and rs of 0.968. The average bias between AccuChek Inform II and Cobas c701 was -8%. The proportion of women diagnosed with GDM was 25% based on AccuChek Inform II versus 55% for Cobas c701. Results from the external control program showed a bias of approximately 5% for Cobas c701 and no significant bias for AccuChek Inform II. Cobas c701 showed a large bias both towards Accu-Chek Inform II and the reference method used in the external control program, clearly exceeding the desirable bias of <2.6%. The lack of accuracy has great implications on either over- or under-diagnosis of GDM.

The effect of maternal body mass index on duration of induced labor.

INTRODUCTION: Obese primiparous women with induction of labor are at high risk for a cesarean section. There are contradictory results regarding time in induced labor in relation to maternal body mass index (BMI). It is important to characterize the course of induced labor to prevent unnecessary cesarean section. We aimed to evaluate whether the duration of labor was associated with maternal BMI in primiparous women with induction of labor. MATERIAL AND METHODS: A national retrospective cohort study, including 15 259 primiparae with a single term pregnancy, admitted for induction of labor from January 2014 to August 2017. Data were obtained from the Swedish Pregnancy Registry. Cox regression analyses were used to illustrate the association between BMI and active labor and between BMI and time from admission until start of active labor. RESULTS: Duration of active labor was shorter in underweight women and prolonged in women with BMI ≥40 kg/m2 compared with women in other BMI classes, illustrated by Cox regression graphs (P < .001). The median durations of active labor in underweight women were 6.1 and 7.4 hours in women with BMI ≥40 kg/m2 . The time from admission until start of active labor increased with maternal BMI, illustrated by Cox regression graphs (P < .001) and the median duration increased from 12.9 hours in underweight women to 22.6 hours in women with BMI ≥40 kg/m2 . The cesarean section rate in active labor increased significantly with BMI (P < .001) from 7.4% in underweight women to 22.0% in women with BMI ≥40 kg/m2 . Obese and normal weight women had similar rates of spontaneous vaginal delivery (69.9% in the total study population). CONCLUSIONS: The duration of active labor was associated with maternal BMI for underweight women and women with BMI ≥40 kg/m2 . Although women with BMI ≥40 kg/m2 who reached the active phase of labor had the same chance for a spontaneous vaginal delivery as normal weight women, the duration of active labor and the cesarean section rate were increased. The time from admission until start of active labor increased successively with maternal BMI.

Anovaginal distance and obstetric anal sphincter injury: a prospective observational study.

INTRODUCTION AND HYPOTHESIS: No measurements are available for diagnosing the extent of obstetric lacerations. The primary aim of this study was to evaluate the relation between the anovaginal distance (AVD) measured with transperineal ultrasound immediately after delivery and external anal sphincter injury. A secondary aim was to assess whether the palpated perineal thickness was associated with the AVD. METHODS: A prospective observational study of 150 primiparous women at the University Hospital, Linköping, Sweden. After vaginal delivery, initial inspection and palpation of the perineal thickness were performed by the midwife. The women were then divided into subgroups depending on the degree of the suspected perineal laceration. Transperineal ultrasound of the AVD was performed by a physician. Diagnostics of the perineal laceration were done according to standard care. RESULTS: Women with an external sphincter injury had a shorter AVD and shorter palpatory perineal thickness compared with women without anal sphincter injury. No external sphincter injuries were diagnosed when the AVD and/or palpation height was > 20 mm. The mean AVD in the group with probable second-degree laceration (n = 85) was 18.8 mm (95% CI 17.8-19.8), in suspected third-degree laceration (n = 33) 15.7 mm (95% CI 13.7-17.7) and in probable third-degree laceration (n = 32) 11.8 mm (95% CI 9.7-13.9) (p < 0.001). CONCLUSIONS: A short AVD could be a warning sign postpartum and should increase the awareness of possible external sphincter injury before suturing. An AVD of 20 mm seems to indicate a cutoff level of the occurrence of external sphincter injury, but this needs further evaluation.

The impact of obstetric interventions and complications on women's satisfaction with childbirth a population based cohort study including 16,000 women.

BACKGROUND: As a quality marker and a tool for benchmarking between units, a visual analogue scale (VAS) (ranging from 1 to 10) to estimate woman's satisfaction with childbirth was introduced in 2014. This study aimed to assess how obstetric interventions and complications affected women's satisfaction with childbirth. METHODS: A retrospective cohort study including 16,775 women with an available VAS score who gave birth between January 2016 and December 2017. VAS score, maternal and obstetric characteristics were obtained from electronic medical records and crude and adjusted odds ratios (aOR) were calculated. RESULTS: The total prevalence of dissatisfaction with childbirth (VAS 1-3) was 5.7%. The main risk factors for dissatisfaction with childbirth were emergency cesarean section, aOR 3.98 95% confidence interval (CI) 3.27-4.86, postpartum hemorrhage ≥2000 ml, aOR 1.85 95%CI 1.24-2.76 and Apgar score < 7 at five minutes, aOR 2.95 95%CI 1.95-4.47. The amount of postpartum hemorrhage showed a dose-response relation to dissatisfaction with childbirth. Moreover, labor induction, instrumental vaginal delivery, and obstetric anal sphincter injury were significantly associated with women's dissatisfaction with childbirth. A total number of 4429/21204 (21%) women giving birth during the study period had missing values on VAS. A comparison of characteristics between women with and without a recorded VAS score was performed. There were statistically significant differences in maternal age and maternal BMI between the study population and excluded women due to missing values on VAS. Moreover, 64% of the women excluded were multiparas, compared to 59% in the study population. CONCLUSIONS: Obstetric interventions and complications, including emergency cesareans section and postpartum hemorrhage, were significantly related to dissatisfaction with childbirth. Such events are common and awareness of these associations might lead to a more individualized care of women during and after childbirth.

Interobserver agreement in perineal ultrasound measurement of the anovaginal distance: a methodological study.

INTRODUCTION AND HYPOTHESIS: Objective outcome measures of the extent of laceration at delivery are needed. In this study we evaluated and describe here a method for learning perineal ultrasound measurement of the anovaginal distance (AVD). The learning period needed for examiners proficient in vaginal ultrasound examination and the interobserver agreement after reaching proficiency in AVD measurement were determined. The hypothesis was that the method is feasible to learn and reproducible for use in further research. METHODS: The method was taught by an examiner experienced in perineal ultrasonography. The distance between the mucosal margin of the internal anal sphincter was measured with a vaginal probe. The studied examiners measured the AVD until similar results (±5 mm) were achieved. The AVD in 40 women was then measured and documented by two examiners who were blinded to each other's results. Interobserver agreement was calculated using the kappa score. RESULTS: Examiners with previous experience in vaginal ultrasonography had learned the method after performing five sets of comeasurements. The AVD measurements after the learning period showed almost perfect agreement (κ = 0.87) between the examiners. CONCLUSIONS: The method for perineal ultrasound measurement of AVD was learned quickly with high interobserver agreement. The method is feasible to learn and reproducible for use in further research.

Ten years of simulation-based shoulder dystocia training- impact on obstetric outcome, clinical management, staff confidence, and the pedagogical practice - a time series study.

BACKGROUND: To assess the impact of 10 years of simulation-based shoulder dystocia training on clinical outcomes, staff confidence, management, and to scrutinize the characteristics of the pedagogical practice of the simulation training. METHODS: In 2008, a simulation-based team-training program (PROBE) was introduced at a medium sized delivery unit in Linköping, Sweden. Data concerning maternal characteristics, management, and obstetric outcomes was compared between three groups; prePROBE (before PROBE was introduced, 2004-2007), early postPROBE (2008-2011) and late postPROBE (2012-2015). Staff responded to an electronic questionnaire, which included questions about self-confidence and perceived sense of security in acute obstetrical situations. Empirical data from the pedagogical practice was gathered through observational field notes of video-recordings of maternity care teams participating in simulation exercises and was further analyzed using collaborative video analysis. RESULTS: The number of diagnosed shoulder dystocia increased from 0.9/1000 prePROBE to 1.8 and 2.5/1000 postPROBE. There were no differences in maternal characteristics between the groups. The rate of brachial plexus injuries in deliveries complicated with shoulder dystocia was 73% prePROBE compared to 17% in the late postPROBE group (p > 0.05). The dominant maneuver to solve the shoulder dystocia changed from posterior arm extraction to internal rotation of the anterior shoulder between the pre and postPROBE groups. The staff questionnaire showed how the majority of the staff (48-62%) felt more confident when handling a shoulder dystocia after PROBE training. A model of facilitating relational reflection adopted seems to provide ways of keeping the collaboration and learning in the interprofessional team clearly focused. CONCLUSIONS: To introduce and sustain a shoulder dystocia training program for delivery staff improved clinical outcome. The impaired management and outcome of this rare, emergent and unexpectedly event might be explained by the learning effect in the debriefing model, clearly focused on the team and related to daily clinical practice.